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GlaxoSmithKline States its Commitment to Clinical Trial Transparency

A couple of months back I wrote an article about Ben Goldacre and his website AllTrials, an online movement dedicated to the registration of all clinical trials and the public availability of all trial results. This week, British pharma giant, GSK (esteemed purveyors of legendary beverages, Lucozade and Ribena) has furthered its commitment to clinical trial transparency since signing up to the AllTrials campaign in February 2013, committing to make its clinical study reports (CSRs) publicly available through its clinical trials register after approval, termination and publication. CSRs are formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to regulatory agencies. According to the GSK website, the main updates to the company’s commitment include:

- A new online system which will enable researchers to request access to patient level data from GSK clinical trials to help further scientific understanding and improve patient care.

- A panel of independent experts which will review research proposals for access to anonymised patient level data.

- First step towards the ultimate aim of broader system in which data from multiple organisations are made available for research through an independent data custodian.

In response to the GSK announcement Ben Goldacre said: “GSK have made some great promises, and I hope they will deliver. Perhaps most significant is the discussion of collaboration with other companies, to develop a shared platform for access to trial data. These are systemic issues, and first movers will have a huge advantage.”

The main hope here is that clinical trial transparency will become the norm and not some optional extra.

“Doctors, researchers, and patients need access to all the results, for all trials, of all uses, of all currently prescribed treatments, to make safe and informed decisions about which is best. The only discussion to be had on individual patient data is best practice for greater transparency. As the EMA have said: we need to discuss how, not whether, this will happen.”